Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

70795

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 25, 2019

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OXQ

Product Code Name

Dressing change tray

Public Device Record Key

d0db3186-93df-4329-a490-a152e42f3dc4

Public Version Date

April 29, 2019

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

20809160088033

Quantity per Package

20

Contains DI Package

10809160088036

Package Discontinue Date

April 25, 2019

Package Status

Not in Commercial Distribution

Package Type

-